MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-21 for RESUS, ADLT W/MASK, 40" TBG, 6/CS 2K8005 manufactured by Vyaire Medical, Inc.
[92650126]
Currently awaiting for the sample. Once the investigation is complete a follow up submission will be filed.
Patient Sequence No: 1, Text Type: N, H10
[92650127]
Md was attempting a stat intubation in ed. The ambu bag with mask was attached to wall o2 at 15 l/ 100%. As the md attempted to use the bag with mask on the patient prior to intubation, the internal o2 tubing disconnected from the bag. The o2 tubing was not able to be reconnected to the bag. The patient presented to the trauma bay of the ed and needed emergency intubation due to their status. The clinicians were bagging the patient and noticed they were unable to stabilize the patient as the patient was desaturating and hypotensive. While bagging the patient, the clinician noticed that the oxygen tubing had become disconnected from the resuscitative device and was unable to be reinserted to continue bagging. Another device was grabbed and was successful at ventilating the patient. The patient was easily intubated and ventilated. However, later in the course of the stay at ed, the patient ended up crashing and coding and eventually expired.
Patient Sequence No: 1, Text Type: D, B5
[106171732]
One open sample was received for evaluation. After performing a visual inspection to the affected sample it was observed that the tube was detached from the threaded o2 housing. Both components showed a poor evidence of solvent. It is considered that assembly personnel are related to the disconnection of the resuscitator by applying an inadequate amount of the solvent on the union between the pvc tubing and the housing for a complete assembly of the product. Since the defect was provoked due to a lack of solvent, personnel were re-trained and notified about this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00384 |
| MDR Report Key | 7049414 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-21 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-11-06 |
| Date Mfgr Received | 2017-12-07 |
| Date Added to Maude | 2017-11-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MINDY FABER |
| Manufacturer Street | 26125 N RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO. 85., PARQUE INDUSTRIAL MEX |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESUS, ADLT W/MASK, 40" TBG, 6/CS |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | OEV |
| Date Received | 2017-11-21 |
| Returned To Mfg | 2017-11-28 |
| Catalog Number | 2K8005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD METTEWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2017-11-21 |